The primary study endpoint is a composite of International Society on Thrombosis and Haemostasis (ISTH) major bleeding/clinically relevant non-major bleeding (CRNM) in subjects undergoing elective total knee or hip replacement [ Time Frame: Up to End of Treatment+2 days (Up to Day 35+2 for THR subjects and up to Day 12+2 for TKR subjects) ] [ Designated as safety issue: Yes ]

ISTH major bleeding is;

Fatal or

Bleeding in a critical organ, such as brain, spine, eye, retroperitoneum, joint, heart sac, or skeletal muscle (and resulting in compartment syndrome), or

Bleeding that results in a fall of hemoglobin of 2 g/dL or more or transfusion of 2 units or more of packed red cells or whole blood within 24 hours

CRNM bleeding is;

Is clinically acute and overt

Does not satisfy criteria as a major bleed but requires medical intervention, such as a visit to a physician's office, emergency room, or urgent care center for epistaxis

THR = Total hip replacement

TKR = Total knee replacement

Secondary Outcome Measures:

Composite of VTE/all cause death, where VTE is the combination of deep vein thrombosis and non-fatal pulmonary embolism [ Time Frame: Up to end of treatment+2 days (Up to Day 35+2 for THR subjects and up to Day 12+2 for TKR subjects) ] [ Designated as safety issue: Yes ]

Apixaban 2.5 mg tablets by mouth twice daily, 12 days for TKR subjects or 35 days for THR subjects

Drug: Apixaban

Other Names:

Eliquis

BMS-562247

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Age ≥18 years

Subjects undergoing elective total knee or hip replacement or a revision of at least one component of a total knee or hip replacement

Exclusion Criteria:

Women who are pregnant or breastfeeding

Known or suspected, acquired or bleeding or coagulation disorder in the subject or a first degree relative

Active bleeding or at high risk for bleeding.

Brain, spinal, ophthalmologic, or major surgery or trauma within the past 90 days other than the elective knee/hip surgery

Active hepatobiliary disease

Hemoglobin <9 g/dL

Platelet count <100,000/mm3

Creatinine clearance <30 mL/min

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01884337